The South African Health Products Regulatory Authority (Sahpra) has taken a significant step in the fight against mpox, previously known as monkeypox, by granting approval for the Alinity m MPX assay. This marks the first in vitro diagnostic (IVD) test for the virus.
The approval process was expedited through the World Health Organization's (WHO) Prequalification (PQ) assessment and Emergency Use Listing (EUL). Dr. Boitumelo Semete-Makokotlela, the Chief Executive Officer of Sahpra, highlighted that the swift listing of this diagnostic tool represents a crucial advancement in improving global access to mpox testing. She noted that this achievement underscores the importance of utilizing regulatory reliance mechanisms to enhance health outcomes.
In light of the ongoing mpox outbreaks, the emergency use authorization of the Alinity m MPX assay, which was developed by Abbott Molecular Inc. and is licensed to Abbott Laboratories South Africa (Pty) Ltd, is particularly vital. The nature of mpox demands prompt and precise testing to ensure early detection, effective treatment, and successful containment of the virus.
Currently, Sahpra is only considering nasopharyngeal RT-PCR (reverse transcription polymerase chain reaction) tests for mpox diagnostics. Health organizations, including the African Centres for Disease Control and Prevention (Africa CDC) and the WHO, have pointed out the absence of independently validated antigen rapid diagnostic tests (RDTs) in the market that meet the necessary clinical sensitivity of at least 80% for mpox testing.
Consequently, the use of antigen and antibody rapid test kits, including self-test options, is not recommended at this time.
For those interested in the regulatory requirements surrounding mpox diagnostics, Sahpra has provided a comprehensive communication to industry stakeholders, detailed under Issue No.: MD01-2024/25 v1. This document is accessible on Sahpra’s official website, which also offers guidance on further WHO recommendations related to mpox diagnostics.
This approval is a significant milestone in the global health landscape, as it aims to enhance the capacity for mpox testing and ultimately contribute to better health outcomes in the face of ongoing public health challenges.
The approval process was expedited through the World Health Organization's (WHO) Prequalification (PQ) assessment and Emergency Use Listing (EUL). Dr. Boitumelo Semete-Makokotlela, the Chief Executive Officer of Sahpra, highlighted that the swift listing of this diagnostic tool represents a crucial advancement in improving global access to mpox testing. She noted that this achievement underscores the importance of utilizing regulatory reliance mechanisms to enhance health outcomes.
In light of the ongoing mpox outbreaks, the emergency use authorization of the Alinity m MPX assay, which was developed by Abbott Molecular Inc. and is licensed to Abbott Laboratories South Africa (Pty) Ltd, is particularly vital. The nature of mpox demands prompt and precise testing to ensure early detection, effective treatment, and successful containment of the virus.
Currently, Sahpra is only considering nasopharyngeal RT-PCR (reverse transcription polymerase chain reaction) tests for mpox diagnostics. Health organizations, including the African Centres for Disease Control and Prevention (Africa CDC) and the WHO, have pointed out the absence of independently validated antigen rapid diagnostic tests (RDTs) in the market that meet the necessary clinical sensitivity of at least 80% for mpox testing.
Consequently, the use of antigen and antibody rapid test kits, including self-test options, is not recommended at this time.
For those interested in the regulatory requirements surrounding mpox diagnostics, Sahpra has provided a comprehensive communication to industry stakeholders, detailed under Issue No.: MD01-2024/25 v1. This document is accessible on Sahpra’s official website, which also offers guidance on further WHO recommendations related to mpox diagnostics.
This approval is a significant milestone in the global health landscape, as it aims to enhance the capacity for mpox testing and ultimately contribute to better health outcomes in the face of ongoing public health challenges.
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